Comparing Insulin Prices in the United States to Other Countries: Updated Results Using 2022 Data.

Manufacturers' list prices for insulin have increased dramatically over the past decade in the United States. In this study, the authors present results from a comparison of U.S. and international prices for insulins using a price index approach. They compare prices for all insulins and different categories of insulin in the United States and 33 comparison Organisation for Economic Co-operation and Development countries. They present separate comparisons using U.S. manufacturer gross prices reflected at pharmacies and estimated manufacturer net prices after applying rebates paid by manufacturers. This study updates a prior RAND Corporation study, Comparing Insulin Prices in the United States to Other Countries: Results from a Price Index Analysis, with more-recent data and includes new supplementary analyses, editorial changes, and updates to reflect the evolving insulin market landscape.

Comparing New Prescription Drug Availability and Launch Timing in the United States and Other OECD Countries.

Prescription drug research and development is, particularly in its most expensive later stages, an increasingly global endeavor undertaken by large, multinational firms. However, the availability of the resulting new drugs in individual countries and the timing of their launch can vary because of regulatory differences, business decisions, and other factors. The now-enacted Inflation Reduction Act of 2022 and other policy proposals aim to lower U.S. prices for brand-name drugs that are between three and four times as expensive as in other higher-income countries. Some stakeholders assert that lower U.S. prices will prevent U.S. patients from accessing some drugs sold in other countries or delay the launch of new drugs in the United States. To address these concerns, the author uses 2018 to 2022 data to compare the availability and timing of entry of new prescription drugs between the United States and other high-income countries.

International Prescription Drug Price Comparisons: Estimates Using 2022 Data.

Understanding the extent to which prescription drug prices are higher in the United States than in other countries-after accounting for differences in the volume and mix of drugs-is useful when developing and targeting policies to address both growth in drug spending and the financial impact of prescription drugs on consumers. This study summarizes findings from comparisons of drug prices in the United States and other high-income countries based on 2022 data and presents results for specific types of drugs, including brand-name originator drugs and unbranded generic drugs, and from sensitivity analyses.

Claims-Based Reporting of Post-Operative Visits for Procedures with 10- or 90-Day Global Periods: Updated Results Using Calendar Year 2018 Data.

Medicare payments for most surgical procedures cover both procedures and post-operative visits occurring within a global period of either ten or 90 days following procedures. There have been concerns that fewer post-operative visits are provided than the number of post-operative visits considered when the procedure was valued. To help inform accurate valuation of procedures with global periods, the Centers for Medicare & Medicaid Services (CMS) required select practitioners to report on post-operative visits after select procedures with 10- or 90-day global periods. The authors of this article summarize patterns of post-operative visits for procedures furnished during calendar year 2018, building on prior research that analyzed data for procedures with July 1, 2017, through June 30, 2018, service dates. During calendar year 2018, 96.5 percent of procedures with 10-day global periods did not have an associated post-operative visit. Approximately two-thirds of procedures with 90-day global periods had an associated post-operative visit; however, the ratio of observed to expected post-operative visits provided for 90-day global period procedures was only 0.38. Underreporting of post-operative visits might be driving these low rates. However, in sensitivity analyses limited to practitioners who were actively reporting their post-operative visits, post-operative patterns were largely similar to the main analysis. Collectively, these findings suggest that a large share of expected post-operative visits are not delivered, and that underreporting is unlikely to fully explain the low ratio of expected post-operative visits provided.

Claims-Based Reporting of Post-Operative Visits for Procedures with 10- or 90-Day Global Periods: Updated Results Using Calendar Year 2019 Data.

Medicare payments for most surgical procedures cover both procedures and post-operative visits occurring within a global period of either 10 or 90 days following procedures. There have been concerns that fewer post-operative visits are provided than the number of post-operative visits considered when the procedure was valued. To help inform accurate valuation of procedures with global periods, the Centers for Medicare & Medicaid Services (CMS) required select practitioners to report on post-operative visits after select procedures with 10- or 90-day global periods. The authors of this article summarize patterns of post-operative visits for procedures furnished during calendar year 2019, building on prior research that analyzed data for procedures furnished from July 1, 2017, through June 30, 2018, and for the entire 2018 calendar year. During calendar year 2019, 96.5 percent of procedures with 10-day global periods did not have an associated post-operative visit. Approximately two-thirds of procedures with 90-day global periods had an associated post-operative visit; however, the ratio of observed to expected post-operative visits provided for 90-day global period procedures was only 0.38. Underreporting of post-operative visits might be driving these low rates. However, in sensitivity analyses limited to practitioners who were actively reporting their post-operative visits, post-operative patterns were largely similar to the main analysis. Collectively, these findings suggest that many expected post-operative visits are not delivered and that underreporting is unlikely to fully explain the low ratio of expected post-operative visits provided.

Prescription Drug Supply Chains: An Overview of Stakeholders and Relationships.

The authors describe the stakeholders involved in prescription drug supply chains and the flows of products, payments, and information between stakeholders. Many stakeholders and steps are involved in the life cycle of a prescription drug as it moves from chemical synthesis and formulation through dispensing or administration to patients. The specific steps involved in prescription drug supply chains often differ depending on the type of drug, the channel of distribution, and the patient's source of prescription drug coverage. Although the authors present a typical supply chain for retail pharmacy drugs, they also highlight the important supply chain distinctions for specific distribution channels and for specific types of drugs. Disparate sources exist describing each component of the supply chain, but, to the authors' knowledge, this study is the first to compile them to facilitate understanding of their interdependence and complexity. The typical stakeholders, relationships, and financial incentives in prescription drug supply chains vary depending on the characteristics of a drug and how it reaches patients. Even within a specific type of drug and a particular distribution channel, differences in business practices complicate a universal description of drug supply chains. There are four common core components of drug supply chains: manufacturing, distribution, coverage and payment, and prescribing and demand. Although prescription drugs are generally available to dispense when prescribed in the United States, there are important exceptions that warrant further investigation. The ability of policymakers to identify, assess, and respond to shortages and disruptions in supply chains is hampered by incomplete data.

Using Claims-Based Estimates of Post-Operative Visits to Revalue Procedures with 10- and 90-Day Global Periods: Updated Results Using Calendar Year 2019 Data.

Medicare payment for many health care procedures covers not only the procedure itself but also most post-operative care over a fixed period of time (the ""global period""). The Centers for Medicare & Medicaid Services (CMS) sets payment rates assuming that a certain number and type of post-operative visits specific to each procedure typically occur. This article describes how CMS might use claims-based data on the number of post-operative visits to adjust valuation for procedures with 10- and 90-day global periods. There are links between the number of bundled post-operative visits and the components of valuation addressed in this study: work, practice expense (PE), and malpractice relative value units (RVUs). There is some ambiguity regarding how a reduction in post-operative visits translates into changes in work RVUs. In contrast, a reduction in post-operative visits has clear implications on physician time and direct PE. Changes in physician work, physician time, and direct PE will, in turn, affect the allocation of pools of PE and malpractice RVUs to individual services. The idiosyncrasies of the resource-based relative value scale system used to determine payment for Medicare services result in some ambiguity about how procedures should be revalued to reflect reductions in post-operative visits. These results may inform further policy development around revaluation for global procedures.

Projected US savings from biosimilars, 2021-2025.

OBJECTIVES: Biologics account for an increasing share of US prescription drug spending. Biosimilars could lower biologic prices through competition, but barriers to increasing both supply and uptake remain. We projected US biosimilar savings from 2021 to 2025 under different scenarios. STUDY DESIGN: We projected US spending on biologics over a 5-year period under 3 scenarios: (1) a baseline scenario holding quarter 4 (Q4) of 2020 market conditions constant; (2) under main assumptions allowing for biosimilar market growth and entry; and (3) an upper-bound scenario assuming greater biosimilar uptake, more robust price competition, and quicker biosimilar entry. METHODS: We first analyzed 2014-2020 US volume and price data from IQVIA's MIDAS database for biologics already facing biosimilar competition to inform model parameter values. We used these inputs to project biosimilar entry, biosimilar volume shares, biosimilar prices, and reference biologic prices. We calculated 2021-2025 new savings from biosimilar competition vs the Q4 2020 baseline. RESULTS: Estimated biosimilar savings from 2021 to 2025 under our main approach were $38.4 billion, or 5.9% of projected spending on biologics over the same period. Biologics first facing biosimilar competition from 2021 to 2025 accounted for $26.1 billion of savings, with $12.2 billion from evolving market conditions for already-marketed biosimilars. Furthermore, $24.6 billion of savings under our main approach were from downward pressure on reference biologic prices rather than lower biosimilar prices. Savings were substantially higher ($124.5 billion) under the upper-bound scenario. CONCLUSIONS: Biosimilar savings from 2021 to 2025 were $38.4 billion under our main assumptions. Greater savings may be feasible if managed care and other settings increase biosimilar utilization and promote competition.

Variation in Estimated Surgical Procedure Times Across Patient Characteristics and Surgeon Specialty.

Importance: The time involved in performing a procedure is a key factor in determining physician payments by Medicare. However, there are long-standing concerns regarding the accuracy of the time estimates generated by the American Medical Association/Specialty Society Relative Value Scale Update Committee surveys that are used in the valuation process, and there have been calls to use other data sources to estimate procedure times. Objective: To compare estimated procedure times that come from claims with the times used in Medicare's valuation process. Design and Setting: Building off prior work using Medicare fee-for-service claims, procedure times were estimated from linked anesthesia claims data for 1349 different Current Procedure Terminology codes that are typically performed with anesthesia. All procedures in the nation performed in 2018 for Medicare fee-for-service beneficiaries were included in the analysis. These estimated times were compared with the times used in the valuation process. Analysis took place from February to November 2021. Main Outcomes and Measures: Estimated procedure times using anesthesia claims were compared with the procedure time used in valuation by calculating an estimated-to-valuation procedure time ratio for each code. The valuation procedure time is publicly reported by Medicare. The mean and median ratio are presented over all procedures and for select high-volume codes as well as by patient characteristics (age, sex, and risk score) and specialty of the physician performing the procedure. Results: Across 4.9 million procedures in this analysis, the mean estimated procedure time was 27% lower than the time used in the valuation process. There were notable exceptions, for which the mean estimated procedure time equaled or exceeded the valuation time including total hip arthroplasty (5% longer) and total knee arthroplasty (equal duration). Within a given code, older patients and those with more illness had longer procedure times. There was substantial variation across specialties in the percent difference between mean estimated and valuation procedure times ranging from gastroenterology (36% shorter) and ophthalmology (35% shorter) to cardiac surgery (2% longer) and thoracic surgery (7% longer). Conclusions and Relevance: Claims-based procedure times could be used to improve the accuracy of valuations for procedures.

Significance and Factors Associated with Antipsychotic Polypharmacy Utilization Among Publicly Insured US Adults.

Antipsychotic polypharmacy (APP) lacks evidence of effectiveness in the care of schizophrenia or other disorders for which antipsychotic drugs are indicated, also exposing patients to more risks. Authors assessed APP prevalence and APP association with beneficiary race/ethnicity and payer among publicly-insured adults regardless of diagnosis. Retrospective repeated panel study of fee-for-service (FFS) Medicare, Medicaid, and dually-eligible white, black, and Latino adults residing in California, Georgia, Iowa, Mississippi, Oklahoma, South Dakota, or West Virginia, filling antipsychotic prescriptions between July 2008 and June 2013. Primary outcome was any monthly APP utilization. Across states and payers, 11% to 21% of 397,533 antipsychotic users and 12% to 19% of 9,396,741 person-months had some APP utilization. Less than 50% of person-months had a schizophrenia diagnosis and up to 19% had no diagnosed mental illness. Payer modified race/ethnicity effects on APP utilization only in CA; however, the odds of APP utilization remained lower for minorities than for whites. Elsewhere, the odds varied by race/ethnicity only in OK, with Latinos having lower odds than whites (odds ratio 0.76; 95% confidence interval 0.60-0.96). The odds of APP utilization varied by payer in several study states, with odds generally higher for Dual eligibles, although the differences were generally small; the odds also varied by year (lower at study end). APP was frequently utilized but mostly declined over time. APP utilization patterns varied across states, with no consistent association with race/ethnicity and small payer effects. Greater use of APP-reducing strategies are needed, particularly among non-schizophrenia populations.

Factors Associated With Off-Label Utilization of Second-Generation Antipsychotics Among Publicly Insured Adults.

OBJECTIVE: Off-label utilization of second-generation antipsychotic medications may expose patients to significant risks. The authors examined the prevalence, temporal trends, and factors associated with off-label utilization of second-generation antipsychotics among publicly insured adults. METHODS: A retrospective repeated panel was used to examine monthly off-label utilization of second-generation antipsychotics among fee-for-service Medicare, Medicaid, and dually eligible White, Black, and Latino adult beneficiaries filling prescriptions for second-generation antipsychotics in California, Georgia, Mississippi, and Oklahoma from July 2008 through June 2013. RESULTS: Among 301,367 users of second-generation antipsychotics, between 36.5% and 41.9% had utilization that was always off-label. Payer did not modify effects of race-ethnicity on off-label utilization. Compared with Whites, Blacks had lower monthly odds of off-label utilization in all four states, and Latinos had lower odds of utilization in California and Georgia. Payer was associated with off-label utilization in California, Mississippi, and Oklahoma. California Medicaid beneficiaries were 1.12 (95% confidence interval=1.10-1.13) times as likely as dually eligible beneficiaries to have off-label utilization. Off-label utilization increased relative to the baseline year in all states, but a downward trend followed in three states. CONCLUSIONS: Off-label utilization of second-generation antipsychotics was prevalent despite the drugs' cardiometabolic risks and little evidence of their effectiveness. The lower likelihood of off-label utilization among patients from racial-ethnic minority groups might stem from prescribers' efforts to minimize risks, given a higher baseline risk for these groups, or from disparities-associated factors. Variation among payers suggests that payer policies can affect off-label utilization.

Estimating the Cost of Industry Investment in Drug Research and Development: A Review of Methods and Results.

Research and development (R&D) costs factor into considerations of the tradeoffs between prices, intellectual property protection, and incentivizing innovation, all of which can have implications for policy development. Yet, there is little consensus on the actual cost of R&D for new drugs. We review and synthesize papers estimating drug R&D costs incurred by industry. We find a substantial range of per-drug costs, from $113 million to just over $6 billion in 2018 dollars. This range includes estimates covering all new drugs, new molecular entities, and drugs in specific therapeutic classes. The range is narrower-$318 million to $2.8 billion-for estimates of the per-drug cost for new molecular entities. We discuss the data sources, methods, and assumptions used in each study to provide context for the wide range in existing estimates. Differences in definitions, methods, and assumptions lead to large divergences in the main estimates, and the combination of fragmented data sources and different assumptions across studies means that the resulting estimates that can rarely be directly compared. We suggest areas for future research and data collection that would result in more comparable and robust estimates to inform ongoing policy discussion.

Patterns of Postoperative Visits Among Medicare Fee-for-service Beneficiaries.

OBJECTIVE: To describe patterns of postoperative visits reported for Medicare fee-for-service (FFS) patients. BACKGROUND: Payment for most surgical procedures bundles postoperative visits within a global period of either 10 or 90 days after a procedure. There is concern that payments for some procedures are excessive because the number of postoperative visits provided is less than the number of postoperative visits used to help determine payment. To obtain data to inform this concern, Medicare required select surgeons to report on their postoperative visits starting July 1, 2017. METHODS: We analyzed Medicare FFS claims data from surgeons who billed Medicare for 1 or more of the 293 common procedure codes between July 1, 2017 and December 31, 2017 in the 9 states where surgeons were required to report postoperative visits. We examined the share of procedures with any reported postoperative visits and the proportion of expected postoperative visits provided. To address concerns about underreporting, we also examined procedures performed by a subset of surgeons actively reporting postoperative visits. RESULTS: We linked 663,681 procedures to 422,432 postoperative visits. The share of procedures with any postoperative visits was higher for procedures with 90-day global periods (70.1%) than for procedures with 10-day global periods (3.7%). The proportions of expected postoperative visits provided for 90-day global and 10-day global periods were 0.37 and 0.04 respectively. Among surgeons actively reporting postoperative visits, the proportions of expected postoperative visits provided were modestly higher (procedures with 90-day global periods=0.46 and 10-day global periods=0.16). CONCLUSIONS: The proportion of expected postoperative visits that were provided is low. These results support the need for a reassessment of payment for surgical procedures.

Access to Medical Treatment for Injured Workers in California: Year 1 Annual Report.

An estimated 16 million workers use workers' compensation (WC) insurance annually in California. Many recent policy changes might have affected access to care for injured workers. For this study, the authors assess the various dimensions of access to care in the evolving policy environment to ensure that injured workers have adequate access to needed medical care and the opportunity to achieve better health outcomes. Access to care is an important domain to monitor, especially among vulnerable populations, as patients with better access to care systems are more likely to receive comprehensive, higher-quality care and are therefore more likely to experience better outcomes. The key objective of this study is to describe access to medical care among injured workers in the state of California, as mandated by Labor Code Section 5307.2. The authors analyze administrative and medical service bill data to examine changes over time for measures related to access to care for injured workers. The authors aim to highlight potential access-to-care barriers in the WC system and to understand whether changes in the WC system may be increasing access for injured workers. Overall, there were increases in claims, bill lines, and spending per provider. Although these increases were moderate to large in number, many of the differences were not statistically significant. These results suggest a concentration of treatment for injured workers, in which a relatively smaller number of providers furnished care to injured workers. Increasing concentration could offer opportunities for specialization in the treatment of work-related injuries. On the other hand, increasing concentration could lead to future access barriers related to scheduling.

Medical Costs for Osteoporosis-Related Fractures in High-Risk Medicare Beneficiaries.

OBJECTIVES: To estimate the incremental direct medical care costs associated with first fracture observable in high-risk older adults. DESIGN: Retrospective analysis of claims and survey data over a 3-year period from the Health and Retirement Study (HRS), a nationally representative biennial study of individuals aged 50 and older. SETTING: United States. PARTICIPANTS: Participants were HRS respondents who consented to have their Medicare claims data linked to the HRS data, were aged 65 or older, had at least 1 risk factor for fracture observable in the data, and experienced a fracture between 1996 and 2008 (n = 689) and their propensity score-matched controls (n = 689). MEASUREMENTS: Total Medicare, inpatient, outpatient, emergency department, physician office visit, and prescription drug care expenditures were primary outcomes. Two-staged generalized linear models were estimated using a difference-in-differences model. RESULTS: Fracture cases' total Medicare expenditures increased by $13,929 (95% confidence interval (CI)=$11,920-15,938, p <.001) more than those of matched controls from the year before the index or fracture date to 1 year after the index date. Inpatient expenditures of $12,751 (95% CI=$10,790-14,7111, p < .001) more for fracture cases than comparison cases primarily drove this increase. Two and 3 years after fracture, there were no significant differences in growth in expenditures between the two groups. Results did not vary according to whether the fracture was at the hip or other site. CONCLUSION: Fractures impose a significant economic burden, especially in the first year after the fracture, in Medicare beneficiaries with at least 1 risk factor for fracture. Our sample was limited to community-dwelling individuals, and we are unable to control for fracture history before the study period. Costs may be greater for those in skilled nursing and similar facilities and for those who have had a previous fracture. J Am Geriatr Soc 66:2298-2304, 2018.